• Job title: Manager Centralized Support Services Team R&D Budapest Hub
• Location: Budapest, Hungary
• Job type: Permanent, full-time
• Hybrid working (60% office, 40% home)

About the job

Sanofi Global Regulatory Affairs (GRA) is looking for a Manager for the Centralized Support Services Team in the R&D Budapest Hub.

In this role you will lead the Records Management team, the User Support Team and resources dedicated to User Acceptability Testing within the R&D Budapest Hub. You will also be the functional lead for Records Management within GRA and will perform operational activities as defined below.

You will be responsible for driving superior regulatory practices by championing operational excellence, organizational alignment, and execution. You will be a critical leader of a highly productive team, a collaborative team player, and driven to solve problems and improve ways of working.

The role reports solid to the Head of Global R&D Budapest Hub.

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. 

Main responsibilities:

People Management:

• Serve as direct line manager for team members, handling P&C matters including performance management, development discussions, compensation, recruitment, and onboarding
• Monitor team performance using defined metrics and ensure quality delivery of all tasks
• Act as Sanofi line manager for external vendors

Records Management Leadership:

• Function as primary contact for information, document, and records management within GRA
• Design and implement global records management organization
• Serve as primary point of contact for records management during audits and inspections
• Guide information and records management practices across all GRA operations

Operational Management:

• Oversee all team tasks and assign resources flexibly based on Records Management and User Support needs
• Ensure team compliance with Sanofi and Health Authority requirements
• Develop team capabilities, integrate new tasks, identify synergies, and implement process improvements
• Coordinate licensing activities including submission preparation and data importation processes
• Maintain Master Active Application List in compliance with SOPs

Cross-functional Collaboration:

• Align closely with Functional Heads and Business Process Owners from Global Submission Management
• Present status updates to cross-functional teams and Senior Management
• Provide training and system access to users regarding records management

Process Development:

• Execute User Acceptance Testing, create job aids and training processes
• Develop and implement metrics for applicable procedures
• Drive operational effectiveness within the Global Regulatory Services Hub organization

About you

Experience:

• 3-5+ years of experience in the pharmaceutical industry
• Solid background in the field of Records Management
• Proven track record in leading teams and developing people, at least on a project management basis

Knowledge, soft skills and competencies:

• Developing people and building a talent pipeline, coaching skills, a team player with orientation towards building and maintaining effective relationships, with strong culture awareness
• Inspiring manager who will leverage his/her commercial awareness and global business acumen to actively contribute to the success of the entire R&D Budapest Hub organization
• Strong communication, negotiation and influencing skills, with a good sense of pragmatism
• Ability to lead complex projects and timelines in a matrix team environment, seasoned with good quality mindset
• Dedicated and persuasive “can-do” attitude and entrepreneurial spirit, problem-solver with critical thinking and open to go the extra mile
• Ability to work under pressure, adaptability to change, solve problems and willingness to learn to drive to meet short deadlines and shift priorities

Technical skills:

• Strong knowledge about electronic archiving systems and understanding of the relationship between systems and electronic databases
• Working knowledge of Veeva Vault RIM or similar Regulatory Information Management tools
• Working knowledge in Microsoft Office and Windows (Outlook, Word, Excel, PowerPoint), and web skills a plus
• Familiarity with Good Documentation Practices (GDP) in a regulated environment

Education:

• Bachelor’s or ideally Master’s degree, or equivalent in Library Science, ITS, Records Management, or similar equivalent related field

Languages:

• Excellent written and verbal communication skills in English

Why choose us?

• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs
• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science
• Bring the miracles of science to life alongside a supportive, future-focused team in an international work environment
• Work from an "Office of the Year 2023" award winner with flexible home office policy
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave
• An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks
• Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)

PursueProgress. Discover Extraordinary.

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Discover our Code of Conduct, that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document before applying.

#Sanofi #SanofiCareers #joinSanofi

#jobopportunities #careeropportunities #sscjob

#Sanofi_Budapest_Hub #Budapest

#R&D #regulatoryaffairs #regulatoryjobs #recordsmanagement #recordsmanager #RIM #archiving #leadership #teamlead #manager

#LI-EUR #LI-hybrid

null

Pursue Progress. Discovery Extraordinary.

Werde Teil von Sanofi und starte mit uns in eine neue Ära der Wissenschaft – wo dein persönliches Wachstum genauso wegweisend ist wie unsere Arbeit. Wir investieren in dich, damit du weiterkommst, schneller denkst und Dinge möglich machst, die vorher undenkbar waren. Du wirst Grenzen verschieben, Gewohntes hinterfragen und smarte Lösungen entwickeln, die direkt bei den Menschen ankommen, für die wir da sind. Bereit, die Wunder der Wissenschaft zu jagen und Leben zu verbessern? Dann lass uns gemeinsam Großes bewegen – und das Außergewöhnliche entdecken.

Bei Sanofi stehen allen die gleichen Chancen offen – unabhängig von Herkunft, Hautfarbe, Religion, Geschlecht, Nationalität, sexueller Orientierung, Alter, Staatsangehörigkeit, Familienstand, Behinderung, Geschlechtsidentität, Veteranenstatus oder anderen gesetzlich geschützten Merkmalen.